Small Molecule Insulin Formulation
The manufacture of biologicals is a many-fold challenge, not the least of which is the need for accurate yet flexible methods and instruments for the detection of bioproduct size, self-association, species discrimination, and lot-to-lot comparability. Of the available methods, analytical ultracentrifugation (AUC) provides superior analysis of higher-order structures, and does so without the need for extensive dilutions or the risk of column-matrix interactions. With AUC’s tolerance for a wide range of buffers, it is the perfect method for assessing how changes in formulation impact a protein’s solution conformation, and, in turn, how formulation and solution conformation impact a biological’s activity.
Insulin’s activity is directly tied to the structure of the protein’s various domains. Analysis of various formulations of insulin provides important information about the effect of different additives on protein aggregation, and their connection to the biological effects seen in patients.